Fluid injector and patient set therefor

ABSTRACT

A syringe manifold ( 300 ) for a fluid injector assembly includes a middle body member ( 304 ) defining an upper cavity ( 308 ) and a lower cavity ( 309 ), the middle body member defining at least one fluid path in an upper surface of the middle body member and at least one fluid path in a lower surface of the middle body member, the middle body member defining at least two ports extending through the middle body member, the middle body member comprising an outlet ( 302 ) for connection of the syringe manifold to at least one fluid delivery device; a lower body member ( 303 ) received within the lower cavity of the middle body member, the lower body member comprising at least one connector for connection of the lower body member to a syringe assembly ( 700 ); and an upper body member ( 305 ) received within the upper cavity of the middle body member.

CROSS REFERENCE TO RELATED APPLICATION

This application is a 371 national phase application of PCTInternational Application No. PCT/US2017/042314, filed Jul. 17, 2017,and claims the benefit of U.S. Provisional Patent Application No.62/363,668, filed Jul. 18, 2016, the disclosures of which areincorporated herein by reference in their entirety.

BACKGROUND OF THE DISCLOSURE Field of the Disclosure

The present disclosure relates generally to medical fluid deliverysystems and apparatuses for delivering one or more medical fluids to apatient.

Description of Related Art

In many medical diagnostic and therapeutic procedures, a medicalpractitioner, such as a physician, injects a patient with one or moremedical fluids. In recent years, a number of injector-actuated syringesand fluid injectors for pressurized injection of medical fluids, such asa contrast media solution (often referred to simply as “contrast”), aflushing agent, such as saline, and other medical fluids, have beendeveloped for use in procedures such as angiography, computed tomography(CT), ultrasound, magnetic resonance imaging (MRI), positron emissiontomography (PET), and other imaging procedures. In general, these fluidinjectors are designed to deliver a preset amount of one or more fluidsat a preset pressure and/or flow rate.

In some injection procedures, the medical practitioner places a catheteror a needle connected to tubing, or other fluid delivery connection intoa vein or artery of the patient. The catheter or the tubing is connectedto either a manual or a powered automatic fluid injection mechanism.Automatic fluid injection mechanisms typically include at least onesyringe connected to a fluid injector having, for example, at least onepowered linear piston. The at least one syringe may include a source ofcontrast and/or a source of flushing fluid. The medical practitionerenters settings into an electronic control system of the fluid injectorfor a fixed volume of contrast and/or saline, a fixed rate of injectionfor each, and specific times for injections of each of the one or morefluids.

The injected contrast and/or saline is delivered to a patient'svasculature through a catheter or needle inserted into the patient'sbody, such as the patient's arm or groin area. A dose of contrast isreferred to as a bolus. Once the bolus of contrast is delivered to thedesired site, that area is imaged using a conventional imagingtechnique, such as angiography imaging, CT imaging, ultrasound, MRI, PETor SPECT imaging, and/or other imaging procedures. The presence of thecontrast becomes clearly visible against the background of thesurrounding tissue.

Conventional injector design includes a controller, including buttonsand readouts, located on the face of the injector assembly whichrequires the user or technician to enter and monitor the injection whileremaining within arms-length of the injector assembly. Further, whenfilling the one or more syringes associated with the fluid injectionsystem, the fluid containers are typically inverted and hung on anadjacent stand. However, there is a need for improved injector designthat provides benefits and ease of use features to allow a user ortechnician to freely move throughout the treatment room and readily fillthe one or more syringes. While various fluid injection systems andmethods are known in the medical field, improved designs and methods foruse of the fluid injector which improve the user experience continue tobe in demand. Particularly, in view of the disadvantages of the existingfluid injection systems that limit user simplicity and experience, thereis need for an improved fluid injection system that provides better userexperience and improved workflow.

SUMMARY OF THE DISCLOSURE

Accordingly, it is an object of the present disclosure to providesystems for delivering fluid to a patient or multiple patients thatovercome some or all of the deficiencies of the prior art.

According to one example of the present disclosure, a syringe manifoldfor a fluid injector assembly includes an upper body member, the upperbody member comprising at least one fluid conducting element forpiercing a fluid container; a middle body member defining an uppercavity and a lower cavity, the upper body member connected with theupper cavity of the middle body member, and the middle body memberfurther comprising: at least one first fluid path defined in an uppersurface of the middle body member; at least one second fluid pathdefined in a lower surface of the middle body member; at least one firstport defined by the at least one first fluid path; at least one secondport defined by the at least one first fluid path and the at least onesecond fluid path; and an outlet for connection of the syringe manifoldto at least one fluid delivery device; and a lower body member connectedwith the lower cavity of the middle body member, the lower body membercomprising at least one connector for connection of the lower bodymember to a syringe assembly, wherein the at least one first port on themiddle body member establishes fluid communication between the at leastone fluid conducting element and the at least one connector, and whereinthe at least one first fluid path, the at least one second fluid path,and the at least one second port establish fluid communication betweenthe at least one connector and the outlet of the middle body member.

In another example of the present disclosure, the at least one fluidconducting element comprises two spike members, and the lower bodymember comprises two connectors. The middle body member comprises twosecond fluid paths in the lower surface of the middle body member, andthe middle body member defines two first ports and two second portsextending through the middle body member. The at least one first port isdefined at a first end of the at least one second fluid path defined inthe lower surface of the middle body member, and the at least one secondport is defined at a second, opposing end of the at least one secondfluid path defined in the lower surface of the middle body member. Acheck valve diaphragm is provided in each of the at least one first portand the at least one second port. A first check valve diaphragmpositioned between the at least one fluid conducting element and the atleast one connector permits fluid flow from the at least one fluidconducting element to the at least one connector and prevents fluid flowfrom the at least one connector to the at least one fluid conductingelement, and a second check valve diaphragm positioned between the atleast one connector and the outlet of the middle body member permitsfluid flow from the at least one connector to the outlet and preventsfluid flow from the outlet to the at least one connector. A floatingdisc valve is provided in each of the at least one first port and the atleast one second port. A first floating disc valve positioned betweenthe at least one fluid conducting element and the at least one connectorpermits fluid flow from the at least one fluid conducting element to theat least one connector and prevents fluid flow from the at least oneconnector to the at least one fluid conducting element, and a secondfloating disc valve positioned between the at least one connector andthe outlet of the middle body member permits fluid flow from the atleast one connector to the outlet and prevents fluid flow from theoutlet to the at least one connector. At least one of the upper bodymember and the lower body member are welded to the middle body member. Asyringe may be connected to the at least one connector.

In another example of the present disclosure, a syringe manifold for afluid injector assembly comprises: an upper body member, the upper bodymember comprising at least one fluid conducting element for piercing afluid container; a middle body member defining an upper cavity and alower cavity, the upper body member connected with the upper cavity ofthe middle body member, the middle body member further comprising: atleast one fluid path in an upper surface of the middle body member; atleast one first port defined by the at least one fluid path; and atleast one second port defined by the at least one fluid path; and alower body member connected with the lower cavity of the middle bodymember, the lower body member comprising: at least one connector forconnection of the lower body member to a syringe assembly; at least onefluid path; and an outlet for connection of the syringe manifold to atleast one fluid delivery device; wherein the at least one first portdefined in the middle body member establishes fluid communicationbetween the at least one fluid conducting element and the at least oneconnector, and wherein the at least one fluid path defined in the lowerbody member, the at least one first port defined in the middle bodymember, the at least one fluid path defined in the upper surface of themiddle body member, and the at least one second port defined in themiddle body establish fluid communication between the at least oneconnector and the outlet of the lower body member.

In another example of the present disclosure, the at least one fluidconducting element comprises two spike members, and the lower bodymember comprises two connectors. The lower body member comprises twofluid paths, and the middle body member comprises four ports extendingthrough the middle body member. The at least one first port provided inthe middle body member is positioned adjacent a first end of the atleast one fluid path defined in the lower body member, and the at leastone second port provided in the middle body member is positionedadjacent a second, opposing end of the at least one fluid path definedin the lower body member. A check valve diaphragm or floating disc valveis positioned between the at least one fluid conducting element of theupper body member and the at least one connector of the lower bodymember. A syringe is connected to the at least one connector.

In another example of the present disclosure, a syringe assemblycomprises: a barrel extending from a conical distal end to a proximalend; an adapter connected to the distal end of the barrel, the adapterconfigured for connection to a connector of a syringe manifold; thesyringe manifold comprising: an upper body member comprising at leastone fluid conducting element for piercing a fluid container; a middlebody member defining an upper cavity and a lower cavity, the upper bodymember connected with the upper cavity of the middle body member; and alower body member connected with the lower cavity of the middle bodymember, the lower body member comprising at least one connector forconnection of the lower body member to the adapter; and a flow directingassembly held within the distal end of the barrel and extending throughthe adapter, wherein the flow directing assembly is configured to directfluid being drawn into the syringe assembly along an inner wall of thebarrel.

In another example of the present disclosure, a portion of the flowdirecting assembly is held between a protrusion extending inwardly froman inner surface of the distal end and a proximal end of the adapter.The flow directing assembly comprises a main body member with at leastone surface that is angled such that fluid being drawn into the syringeassembly is directed along an inner wall of the barrel. A plurality oflocking features is provided on the proximal end of the barrel.

Further examples will now be described in the following numberedclauses.

Clause 1: A syringe manifold for a fluid injector assembly, the syringemanifold comprising: an upper body member, the upper body membercomprising at least one fluid conducting element for piercing a fluidcontainer; a middle body member defining an upper cavity and a lowercavity, the upper body member connected with the upper cavity of themiddle body member, and the middle body member further comprising: atleast one first fluid path defined in an upper surface of the middlebody member; at least one second fluid path defined in a lower surfaceof the middle body member; at least one first port defined by the atleast one first fluid path; at least one second port defined by the atleast one first fluid path and the at least one second fluid path; andan outlet for connection of the syringe manifold to at least one fluiddelivery device; and a lower body member connected with the lower cavityof the middle body member, the lower body member comprising at least oneconnector for connection of the lower body member to a syringe assembly,wherein the at least one first port on the middle body memberestablishes fluid communication between the at least one fluidconducting element and the at least one connector, and wherein the atleast one first fluid path, the at least one second fluid path, and theat least one second port establish fluid communication between the atleast one connector and the outlet of the middle body member.

Clause 2: The syringe manifold of Clause 1, wherein the at least onefluid conducting element comprises two spike members, and wherein thelower body member comprises two connectors.

Clause 3: The syringe manifold of Clause 2, wherein the middle bodymember comprises two second fluid paths in the lower surface of themiddle body member, and wherein the middle body member defines two firstports and two second ports extending through the middle body member.

Clause 4: The syringe manifold of any of Clauses 1-3, wherein the atleast one first port is defined at a first end of the at least onesecond fluid path defined in the lower surface of the middle bodymember, and wherein the at least one second port is defined at a second,opposing end of the at least one second fluid path defined in the lowersurface of the middle body member.

Clause 5: The syringe manifold of any of Clauses 1-4, wherein a checkvalve diaphragm is provided in each of the at least one first port andthe at least one second port.

Clause 6: The syringe manifold of Clause 5, wherein a first check valvediaphragm positioned between the at least one fluid conducting elementand the at least one connector permits fluid flow from the at least onefluid conducting element to the at least one connector and preventsfluid flow from the at least one connector to the at least one fluidconducting element, and wherein a second check valve diaphragmpositioned between the at least one connector and the outlet of themiddle body member permits fluid flow from the at least one connector tothe outlet and prevents fluid flow from the outlet to the at least oneconnector.

Clause 7: The syringe manifold of any of Clauses 1-6, wherein a floatingdisc valve is provided in each of the at least one first port and the atleast one second port.

Clause 8: The syringe manifold of Clause 7, wherein a first floatingdisc valve positioned between the at least one fluid conducting elementand the at least one connector permits fluid flow from the at least onefluid conducting element to the at least one connector and preventsfluid flow from the at least one connector to the at least one fluidconducting element, and wherein a second floating disc valve positionedbetween the at least one connector and the outlet of the middle bodymember permits fluid flow from the at least one connector to the outletand prevents fluid flow from the outlet to the at least one connector.

Clause 9: The syringe manifold of any of Clauses 1-8, wherein at leastone of the upper body member and the lower body member are welded to themiddle body member.

Clause 10: The syringe manifold of any of Clauses 1-9, furthercomprising a syringe connected to the at least one connector.

Clause 11: A syringe manifold for a fluid injector assembly, the syringemanifold comprising: an upper body member; the upper body membercomprising at least one fluid conducting element for piercing a fluidcontainer; a middle body member defining an upper cavity and a lowercavity, the upper body member connected with the upper cavity of themiddle body member, the middle body member further comprising: at leastone fluid path in an upper surface of the middle body member; at leastone first port defined by the at least one fluid path; and at least onesecond port defined by the at least one fluid path; and a lower bodymember connected with the lower cavity of the middle body member, thelower body member comprising: at least one connector for connection ofthe lower body member to a syringe assembly; at least one fluid path;and an outlet for connection of the syringe manifold to at least onefluid delivery device, wherein the at least one first port defined inthe middle body member establishes fluid communication between the atleast one fluid conducting element and the at least one connector, andwherein the at least one fluid path defined in the lower body member,the at least one first port defined in the middle body member, the atleast one fluid path defined in the upper surface of the middle bodymember, and the at least one second port defined in the middle bodyestablish fluid communication between the at least one connector and theoutlet of the lower body member.

Clause 12: The syringe manifold of Clause 11, wherein the at least onefluid conducting element comprises two spike members, and wherein thelower body member comprises two connectors.

Clause 13: The syringe manifold of Clause 11 or 12, wherein the lowerbody member includes two fluid paths, and wherein the middle body memberincludes four ports extending through the middle body member.

Clause 14: The syringe manifold of any of Clauses 11-13, wherein the atleast one first port provided in the middle body member is positionedadjacent a first end of the at least one fluid path defined in the lowerbody member, and wherein the at least one second port provided in themiddle body member is positioned adjacent a second, opposing end of theat least one fluid path defined in the lower body member.

Clause 15: The syringe manifold of any of Clauses 11-14, furthercomprising a check valve diaphragm or floating disc valve positionedbetween the at least one fluid conducting element of the upper bodymember and the at least one connector of the lower body member.

Clause 16: The syringe manifold of any of Clauses 1-15, furthercomprising a syringe connected to the at least one connector.

Clause 17: A syringe assembly comprising: a barrel extending from aconical distal end to a proximal end; an adapter connected to the distalend of the barrel, the adapter configured for connection to a connectorof a syringe manifold, the syringe manifold comprising: an upper bodymember comprising at least one fluid conducting element for piercing afluid container; a middle body member defining an upper cavity and alower cavity, the upper body member connected with the upper cavity ofthe middle body member; and a lower body member connected with the lowercavity of the middle body member, the lower body member comprising atleast one connector for connection of the lower body member to theadapter; and a flow directing assembly held within the distal end of thebarrel and extending through the adapter, wherein the flow directingassembly is configured to direct fluid being drawn into the syringeassembly along an inner wall of the barrel.

Clause 18: The syringe assembly of Clause 17, wherein a portion of theflow directing assembly is held between a protrusion extending inwardlyfrom an inner surface of the distal end and a proximal end of theadapter.

Clause 19: The syringe assembly of Clause 17 or Clause 18; wherein theflow directing assembly comprises a main body member with at least oneangled surface such that fluid being drawn into the syringe assembly isdirected along an inner wall of the barrel.

Clause 20: The syringe assembly of any of Clauses 17-19, furthercomprising a plurality of locking features provided on the proximal endof the barrel.

Clause 21: The syringe assembly of any of Clauses 17-20, wherein thesyringe manifold comprises at least one port defined in the middle bodymember to establish fluid communication between the at least one fluidconducting element and the at least one connector.

Clause 22: The syringe assembly of any of Clauses 17-21, wherein themiddle body member of the syringe manifold defines at least one fluidflow path to establish fluid communication between the syringe assemblyand an outlet defined by the syringe manifold.

While several examples of fluid injection and delivery systems are shownin the accompanying figures and described herein in detail, otherexamples will be apparent to, and readily made by, those skilled in theart without departing from the scope and spirit of the disclosure. Forexample, it is to be understood that this disclosure contemplates that,to the extent possible, one or more features of any example can becombined with one or more features of any other example. Accordingly,the foregoing description is intended to be illustrative rather thanrestrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a front perspective view of a fluid delivery system accordingto an embodiment of the present disclosure;

FIG. 2 is a rear perspective view of the fluid delivery system of FIG. 1according to an embodiment;

FIG. 3 is a front view of the fluid delivery system of FIG. 1 accordingto an embodiment;

FIG. 4 is an exploded rear perspective view of the fluid delivery systemof FIG. 1 according to an embodiment;

FIG. 5 is an illustration of an exemplary graphical user interface foruse with the fluid delivery system of FIG. 1 according to an embodiment;

FIG. 6 is an illustration of a side view of the fluid delivery system ofFIG. 1 according to an embodiment showing reach areas of differentusers;

FIG. 7 is a side view of the fluid delivery system of FIG. 1 accordingto an embodiment set at a maximum height;

FIG. 8 is a side view of the fluid delivery system of FIG. 1 accordingto an embodiment set at a minimum height;

FIG. 9A is an isolated view of a stowable stand in the fluid deliverysystem of FIG. 1 according to an embodiment;

FIG. 9B is an isolated view of the stowable stand of FIG. 9A accordingto an embodiment in a stowed position;

FIG. 9C is an isolated view showing the stowable stand of FIG. 9Aaccording to an embodiment in an extended position;

FIG. 10A is an isolated view of the stowable stand of FIG. 9A accordingto an embodiment having a hook member being rotated into an extendedposition;

FIG. 10B is an isolated view of the hook member of FIG. 10A;

FIG. 10C is an isolated view of the hook member of FIG. 10A;

FIG. 11A is an isolated view showing the stowable stand of FIG. 9Aaccording to an embodiment securing a bottle to the fluid deliverysystem of FIG. 1 using a hook member;

FIG. 11B is an isolated view of the stowable stand of FIG. 9A accordingto an embodiment holding a fluid bottle and a fluid bag;

FIG. 12A is an isolated view showing the stowable stand of FIG. 9Aaccording to an embodiment holding multi-dose fluid bottles;

FIG. 12B is an isolated view showing the stowable stand of FIG. 9Aaccording to an embodiment holding a multi-dose fluid bottle and amulti-dose fluid bag;

FIG. 13A is an isolated view showing multi-dose fluid containersconnected to a manifold assembly according to an embodiment;

FIG. 13B is an exploded view of an air detector coupling used with themanifold assembly of FIG. 13A according to an embodiment;

FIG. 14A is an isolated view of a fluid warmer according to anembodiment of the fluid delivery system of FIG. 1;

FIG. 14B is a schematic view of a fluid warmer according to anotherembodiment of the fluid delivery system of FIG. 1;

FIG. 15 is an isolated view of an embodiment of a recognition systemprovided on the fluid delivery system of FIG. 1 according to anembodiment;

FIG. 16 is an exploded view of the manifold assembly of FIG. 13Aaccording to an embodiment;

FIG. 17A is a front perspective view of the manifold assembly of FIG. 16according to an embodiment;

FIG. 17B is an exploded bottom perspective view of a lower body memberand a middle body member of the manifold assembly of FIG. 16 accordingto an embodiment;

FIG. 17C is a top perspective view of the lower body member and middlebody member of FIG. 17B according to an embodiment;

FIG. 170 is an exploded view of an upper body member and a middle bodymember of the manifold assembly of FIG. 16 according to an embodiment;

FIG. 17E is a front perspective view of a fully-assembled manifoldassembly of FIG. 16 according to an embodiment;

FIG. 18A is an exploded view of a syringe assembly according to anembodiment;

FIG. 18B is a front perspective view of the syringe assembly of FIG. 18Aaccording to an embodiment;

FIG. 18C is an isolated view of an adapter and flow directing ring inthe syringe assembly of FIG. 18A according to an embodiment;

FIG. 19A is an exploded view of a single-use manifold assembly accordingto an embodiment;

FIG. 19B is an exploded view of a lower body member and a middle bodymember of the manifold assembly of FIG. 19A according to an embodiment;

FIG. 19C is an exploded view of the manifold assembly of FIG. 19Aaccording to an embodiment showing welding paths; and

FIG. 190 is a front perspective view of a fully-assembled manifoldassembly shown in FIG. 19A according to an embodiment.

DETAILED DESCRIPTION

For purposes of the description hereinafter, the terms “upper,” “lower,”“right,” “left,” “vertical,” “horizontal,” “top,” “bottom,” “lateral,”“longitudinal,” and derivatives thereof shall relate to the disclosureas it is oriented in the drawing figures. When used in relation to aninjector, the term “proximal” refers to a portion of an injectorfurthest from a syringe port of an injector. The term “distal” refers toa portion of an injector closest to a syringe port of an injector. It isto be understood, however, that the disclosure may assume alternativevariations and step sequences, except where expressly specified to thecontrary. It is also to be understood that the specific devices andprocesses illustrated in the attached drawings, and described in thefollowing specification, are simply illustrative examples of thedisclosure. Hence, specific dimensions and other physicalcharacteristics related to the examples (i.e., examples, variants,variations) disclosed herein are not to be considered as limiting. Asused herein, the term “multi-patient use” means an article that can beutilized for injection procedures for multiple patients withoutcross-contamination of the portions of the multi-patient use articlewith biological fluids of different patients. As used herein, the term“single-patient use” means an article that is utilized for one or moreinjection procedures for a single patient, which is then disposed ofafter the one or more injection procedure on the single patient beforepreparation for injection of a second patient utilizing a newsingle-patient use article.

As used herein, the terms “communication” and “communicate” when used inreference to one or more computer processors, devices, units, oroperating systems, refer to the receipt or transfer of one or moresignals, messages, commands, or other type of data. For one unit ordevice to be in communication with one or more other unit or devicemeans that the one unit or device is able to receive data from and/ortransmit data to the one or more other unit or device. A communicationmay use a direct or indirect connection, and may be wired and/orwireless in nature. Additionally, two or more units or devices may be incommunication with each other even though the data transmitted may bemodified, processed, routed, etc., between the first and second unit ordevice. For example, a first unit may be in communication with a secondunit even though the first unit passively receives data and does notactively transmit data to the second unit. As another example, a firstunit may be in communication with a second unit if an intermediary unitprocesses data from one unit and transmits processed data to the secondunit. In non-limiting examples, a communication may occur through one ormore wired or wireless connections, such as, through one or more wires,through direct wireless protocols such as Bluetooth, Near FieldCommunication (NFC), or other radio frequency protocols, and/or throughindirect wireless communication such as through a local Wi-Fi network orsecure Internet connection. Wireless communication may include, but isnot limited to, any communication that does not require direct wiredcontact between the two communicating units or devices such as via aWi-Fi network, communication via Bluetooth, NFC, or other conventionalwireless system, or other non-wired electromagnetic communicationsystems. It will be appreciated that numerous other arrangements arepossible.

In another non-limiting example, a fluid injection system is provided,having an injector assembly with at least one syringe port, a processor,and a wired or wirelessly connected controller, which may have a touchscreen or other user input device, and/or a display configured forinputting one or more injection parameters and displaying one or moreinjection features. Suitable processors and/or controllers may include,but are not limited to, a central processing unit (CPU), a desktop orlaptop computer, a tablet computer, a smartphone or a personal dataassistant device, or other handheld computer processor. The processormay be in communication with the controller by a wired or wirelesscommunication mechanism.

In additional examples, a fluid injection system may have an injectorassembly with at least one syringe port and, optionally, a controller,wherein the injector assembly further includes a retractable pole orstowable stand configured to extend above the injector assembly andhaving at least one hanging feature or hook member for hanging at leastone fluid container. The fluid container can be a saline bag orcontainer, a multi-dose pharmaceutical liquid container, a containercontaining multiple doses of a contrast or imaging agent, a containercontaining a single dose of a contrast or imaging agent, and variouscombinations thereof.

Various examples of the present disclosure are directed to fluidinjection systems for injecting one or more fluids into a patient duringan injection procedure. The design and features of the fluid injectionsystem provide ease of use and improved user experience, for example byallowing one or more of: closer monitoring of an injection procedure,the ability to move throughout an injection suite during the injectionprocedure while being able to control one or more parameters or featuresof the ongoing injection procedure, provide a fluid injection systemthat includes a portion suitable for use with multiple injectionprotocols, for example throughout a day (i.e., a multi-patient useportion), and a portion suitable for use for a single injection protocolbefore disposal (i.e., a single-patient use portion), provide a fluidinjection system that can quickly fill one or more syringes with one ormore medical fluids, for example from one or more multi-dose containers,prior to an injection protocol, provide a fluid injection system thatcan determine a fluid fill level in the one or more syringes and/ordetermine one or more properties of the fluid such as a fluid type inthe one or more syringes, provide a manifold for connecting the one ormore syringes to the one or more multi-dose containers and connect theone or more syringes to a fluid path set connecting the one or moresyringes to a patient, to allow filling of the one or more syringes withthe medical fluids and delivering the medical fluids to the patient incontrolled volumes, doses and flow rates, as determined by a processand/or user input into the processor. Further features allow for hangingof one or more multi-dose fluid containers on the fluid injection systemfor ready access when filling and/or refilling the one or more syringesassociated with the fluid injection system. In particular examples, thefluid injection systems of the present disclosure may be used forinjection of one or more imaging agents in an imaging procedure, suchas, for example CT scan, MRI, and other imaging procedures.

In specific examples, the fluid injector system may be a front-loadingfluid injector system similar to the various examples of the injectorsdisclosed in U.S. Pat. Nos. 5,383,858, 7,553,294, 7,666,169, 9,173,9959,199,033 and in International Patent Application Nos. PCT/US12/374891,PCT/US15/10825, PCT/US15/27582, PCT/US16/28824, PCT/US16/34140, and inU.S. Patent Application Publication No. 2014/0027009 and Ser. No.14/925,722, and in U.S. Provisional Application Nos. 62/259,708,62/259,891, 62/259,906, the disclosures of which are incorporated byreference in their entirety. Other examples may include new fluidinjector systems designed to include various examples of the interfacedescribed herein.

FIGS. 1-4 illustrate a fluid injection system 10 including a controller150 including a touch screen, according to a non-limiting example of thepresent disclosure. With reference to FIG. 1, a fluid delivery device orinjector 100 (hereinafter referred to as “injector 100”), such as anautomated or powered fluid injector, is adapted to interface with andactuate at least one syringe (not shown), which may be independentlyfilled with a medical fluid, such as contrast media having a desiredconcentration or identity, saline solution, or other desired medicalfluids. The injector 100 may be used during a medical procedure, such asan imaging procedure, to inject the medical fluid into the body of apatient from the at least one syringe (not shown) operated by a fluidcontrol device (not shown), which may be at least partially internal tothe injector 100. In non-limiting examples, the injector 100 may be amulti-syringe injector, wherein a plurality of syringes may be orientedside-by-side or in another arrangement and include plungers separatelyactuated by respective pistons associated with the injector 100, andcontrolled by the fluid control device. In one non-limiting example, twosyringes may be arranged in a side-by-side fashion and filled with twodifferent medical fluids, such as a contrast agent and a salinesolution, and the injector 100 may be configured to deliver fluid to apatient from one or both of the syringes either sequentially orsimultaneously. It will be appreciated that other arrangements arepossible.

With continued reference to FIGS. 1-4, the injector 100 may have ahousing 125 formed from a suitable structural material, such as plastic,a composite material, and/or metal. The housing 125 may be of variousshapes and sizes depending on the desired application. For example, thefluid delivery system 10 may be a freestanding structure having one ormore support portions 118 and 120 connected to a base 244 with one ormore rollers or wheels such that the injector 100 is movable over thefloor. The injector 100 may include at least one syringe port 126 forreleasably connecting the at least one syringe to respective pistonelements. In various examples, the at least one syringe includes atleast one syringe retaining member (not shown) configured for retainingthe syringe within the syringe port 126 of the injector 100. Innon-limiting examples, the at least one syringe retaining member isconfigured to operatively engage a locking mechanism provided on or inthe syringe port 126 of the injector 100 to facilitate self-orientedloading and/or removal of the syringe to and from the injector 100. Thesyringe retaining member and the locking mechanism together define aconnection interface for connecting the syringe to the injector 100.Non-limiting examples of various connection interfaces are described inU.S. Pat. Nos. 9,173,995 and 9,199,033. In other embodiments, syringeport 126 may facilitate self-oriented loading and/or removal of apressure jacket adapted for containing a compressible syringe or rollingdiaphragm syringe, to and from the injector 100 for example as describedin International Patent Application Nos. PCT/US15/57747 andPCT/US15/57751, the disclosures of which are incorporated in theirentirety by this reference.

In certain non-limiting examples, it is desirable to temporarily rotateand/or invert the injector housing 125 including syringe ports between asubstantially vertical position (i.e., with the syringe port(s) pointingupwards), which may facilitate, for example, the loading of a syringeinto a syringe port and/or the filling of a syringe with medical fluid,and an inverted position, which may facilitate, for example,minimization of air bubbles in a medical fluid contained within asyringe from entering the fluid path, or the conducting of an injectionprocedure. Accordingly, in non-limiting examples of the presentdisclosure, the housing 125 may be connected to the support portion 118in a rotatable fashion such that the housing 125 is rotatable relativeto the support portion 118 and retractable pole 200. As shown in FIG. 4,the housing 125 may be removable from the injector 100. Further, a rearaccess cover 122 may be removably connected to a rear surface of thecomponents of the injector 100. The rear access cover 122 may be removedby a technician to access the inner electronics, mechanical features,and cables of the injector 100 for repair or replacement. The rearaccess cover 122 may be a single component or several separate covercomponents.

As shown in FIGS. 6-8, a lower support member 120 may be extended orretracted in a vertical direction to adjust the height of the fluiddelivery system 10 depending, for example, on the operator height and/orreach area (see FIG. 6). An operator may push down on a handle 124 torelease a locking connection between the lower support member 120 and afluid warmer 500 (described in greater detail herein) provided on thelower support member 120. As the handle 124 is pressed down, theoperator can lift or lower the fluid warmer 500 and associated injectorstand 118 to adjust the height of the injector 100. A hydraulic lift(not shown) may be provided in the lower support member 120 to assist inadjusting the height of the fluid delivery system 10. The lower supportmember 120 may include a plurality of members that are arranged in atelescopic manner to allow adjustment of the height of the fluiddelivery system 10. In one example, the height of the injector 100 maybe adjusted up to 250 mm or more, for example the height may be adjustedfrom 0 to 500 mm, or in other embodiments from 0 to 400 mm, and in otherembodiments from 0 to 250 mm. A maximum height of the fluid deliverysystem 10 is depicted in FIG. 7. A minimum height of the fluid deliverysystem 10 is depicted in FIG. 8.

In non-limiting examples, at least one fluid path set (not shown) may befluidly connected with the distal end of the at least one syringe fordelivering medical fluid from the at least one syringe to a catheter,needle, or other fluid delivery connection (not shown) inserted into apatient at a vascular access site. Fluid flow from the at least onesyringe may be regulated by a fluid control module operated by acontroller or processor, such as a detachable touch screen controller150 or any suitable device. The fluid control module may operatevarious, pistons, valves, and/or flow regulating devices to regulate thedelivery of the medical fluid, such as saline solution and contrast, tothe patient based on one or more user selected injection parameters orstandard injection protocols, such as injection flow rate, duration,total injection volume, and/or ratio of contrast media and saline.

Having generally described the structure and function of the fluiddelivery system 10, the various features associated with the presentdisclosure will now be described in reference to the Figures. FIGS. 1-4illustrate an injector 100 according to a non-limiting example of thepresent disclosure. The injector 100 may include an internal fluidcontrol device (not shown) which may be controlled by the controller150.

The controller 150 may include one or more processors, memory, networkinterfaces, and/or the like and may be configured to generate a displaycomprising a graphical user interface (“GUI”) (shown in FIG. 5), whichmay allow a user to view and/or interact with various injectionparameters through graphical icons and visual indicators produced on thedisplay. In non-limiting examples, the controller 150 may be formed as adetachable touch screen controller. The controller 150 may also benon-removably attached to the injector 100. The controller 150 may beused to monitor one or more injection parameters, including, forexample, patient specific information (age, weight, sex, organ to beimaged, dosage of imaging agent, etc.), which may be inputted by theuser or recalled/downloaded from a database, a network, a memory, oranother controller in communication with the system by a wired orwireless communication process. The controller 150 may be furtherconfigured to control various injection parameters which may be inputtedby a user and/or calculated by one or more algorithmic calculationsperformed by the controller 150, the fluid control device, and/oranother controller or processor in communication with the fluid controldevice and/or the controller 150 based on data downloaded from adatabase and/or inputted by a user. Alternatively, the controller 150may be in communication with one or more other processors, where one ormore of the injection parameters may be inputted or stored and thencommunicated to controller 150 by either a wired or wirelesscommunication interface.

Various user selected injection parameters 170 (see FIG. 5) andinjection instructions, such as injection flow rate, injection starttime, duration, total injection volume of each of the one or morefluids, remaining volume to be injected, ratio of injected fluid, volumeof one or more fluid remaining in a multi-dose medical fluid containerafter the injection procedure, and various other parameters associatedwith the contrast media and saline injection fluids may be inputted intoand/or displayed on the touch screen of the controller 150 and may bemanipulated, viewed, or recorded as required by the user by at least oneinput or output mechanism, for example, changing parameters by utilizingthe touch screen and/or one or more additional controllers incommunication with the controller 150. Plunger positions, detectionconfirmation of disposables, volume of air detected in a patient line,onboard temperatures, medical fluid information, and confirmation of aprime sequence completion may be displayed on the controller 150. Manualor virtual buttons such as fill, purge, prime, and inject buttons andinjection start/stop buttons may be included on the controller 150 toadjust the operating parameters of the injector 100. The controller 150may display or produce audible alerts or other information determined bythe fluid control device or the injection system to notify a user of anevent, such as low fluid level of a syringe connected to an injectorport, the size or type of syringe detected in the injector port, thefluid volume of one or more syringes, the contents of one or moresyringes, air detection in one or more syringes, an indication that thesyringe has been previously used, an indication whether the syringe'suseful shelf-life has expired, a lot number, manufacture date orfacility, etc.

In the non-limiting example shown, the controller 150 may be adjustableon the injector housing 125 and may be utilized to operate the fluiddelivery system 10 while attached to the injector housing 125. As shownin FIGS. 7 and 8, the display angle of the controller 150 may beadjustable to accommodate different operators having different heights.A bottom or top portion of controller 150 may rotate upwardly ordownwardly from the injector housing 125 in a range of 0°-15°. It iscontemplated that additional angle ranges may be used in rotating thecontroller 150. In another example, the controller 150 may be detachablefrom the injector housing 125 and may be utilized to operate the fluidinjection system remotely from other positions in the room and/or, fromanother room.

The controller 150 may be in communication with the fluid injectionsystem through one or more wired or wireless communication connections,such as through one or more wires, through direct wireless protocolssuch as Bluetooth, Near Field Communication (NFC) or other radiofrequency protocols, and/or through indirect wireless communication,such as through a local Wi-Fi network or secure Internet connection.However, it will be appreciated that various wired and wirelesscommunication mechanisms may be used in accordance with the presentdisclosure. According to various examples, the controller 150 mayinclude an internal, rechargeable battery, and may be configured tocharge or replenish its electrical charge while connected to theinjector 100 via one or more ports (not shown) which may provideelectrical connections between the controller 150 and injector 100.Additionally or alternatively, the controller 150 may be charged by astandalone charging station or controller, or by connection to anelectrical outlet.

Operation of the injector 100 may include use of any combination of thetouch screen (either monolithic or detachable), soft-touch keys, andhard-touch keys located on the controller 150, the injector 100, or awired or wireless local operation station (not shown). In certainexamples, one or more images from the scanner may be displayed on thecontroller 150 for view by the user. For example, test images to helpdetermine the correct orientation or placement of the patient within thescanner, or to locate or confirm that the bolus of contrast has reachedthe site of interest, may be taken to enhance the imaging process.Further, in certain examples, images may be displayed on the controller150 to allow the user to confirm that the imaging procedure has beensuccessful, that image clarity is sufficient, and/or to allow quickanalysis of the image.

FIG. 5 shows an example of a graphical user interface (GUI) 151 of acontroller 150 in accordance with a non-limiting example of the presentdisclosure, showing various injection parameters 170 for an injectionprocedure, displayed on a screen, such as a touch screen. As describedherein, the various parameters 170 may be monitored, changed, deleted,and/or inputted by the user before, during, and/or after an injectionprocedure, for example by touching the appropriate field on the touchscreen and entering the appropriate data using an electronic data entryfeature, such as a keypad, that appears on the touch screen. In certainexamples, some or all of the parameters may be saved and uploaded to apatient records database either wirelessly or by wired connection fromthe controller 150 or another controller, for example to a hospitalinformation system or network. In configurations, various parameters maybe saved and uploaded automatically and/or in response to a usercommand.

With reference to FIGS. 9A-11B, according to other non-limitingexamples, the fluid delivery system 10 of the present disclosure mayinclude one or more stowable stand comprising one or moreextendible/retractable poles 200 configured to extend above the injectorhousing 125 and having at least one hanging feature or hook member suchas, for example, one or more pivotable hooks 250 for hanging at leastone container such as a multi-dose fluid container in an appropriateposition above the injector assembly. According to various examples, thefluid delivery system 10 of the present disclosure may be used formultiple sequential injection procedures, wherein the system includes amulti-patient use portion and a single-patient use portion. In theseexamples, the at least one syringe may be a multi-use syringe that maybe repeatedly refilled with the appropriate medical fluid between aseries of fluid injection procedures from at least one multi-dose fluidcontainer, such as a saline bag or container, a bulk contrast bottle, orother appropriate bulk medical container.

For ease of use and convenience, the at least one multi-dose fluidcontainer may be suspended in an inverted position above the housing 125from a hanging feature 250 such as a hook, tray, or other protrusion,while filling or refilling the at least one syringe or additionallyduring the injection procedure where the fluid container is not in fluidcommunication with the at least one syringe. Thus, the multi-dose fluidcontainers may be readily available after an injection procedure torefill the at least one syringe, fill one or more new syringes (in asingle-dose protocol), and/or prepare the fluid injection system for asubsequent injection procedure.

FIGS. 9A-9C illustrate one embodiment of an injector 100 having astowable stand comprising a retractable pole 200 according to anon-limiting example of the fluid injection system of the presentdisclosure. Referring to FIG. 9C, the retractable pole 200 is shown in aretracted or stowed position for storage and to minimize the height ofthe injector 100 as well as eliminate the requirement for a separaterollable IV pole to hang the one or more medical fluid containers. Theretractable pole 200 includes a handle 210 or other gripping surfaceconfigured for gripping by a user and to facilitate the extension and/orretraction of the pole 200 upwards above the support portion 118.Alternatively, the retractable stand may be spring loaded, motorized, orhydraulically operated to move between the stowed and the deployedpositions. In certain examples, retractable pole 200 may be held orlocked in a specific position that may be disengaged by pressing button230 before or concurrently with moving handle 210. In other embodimentswhere retractable stand 220 is motorized or hydraulic, a button on theGUI of the controller may be used to extend and/or retract pole.

FIG. 9C illustrates an embodiment of injector 100 with the retractablepole 200 in an extended or deployed position. In the non-limitingexample shown, the retractable pole 200 is provided with a plurality ofpivotable hooks 250 or hanging features with at least one hook member250 being pivotable from a retracted position, wherein hook 250 issubstantially contained within or aligned parallel with the handle 210,to a deployed position wherein the at least a portion of hook 250rotates and extends perpendicular to the handle 210 either over the atleast one syringe or extending behind the injector. With reference toFIGS. 10A-10C, after the hooks 250 have rotated perpendicular to thehandle 210, the height of the hooks 250 on the poles 200 may be adjustedindependently depending on the desired height for holding the specificmedical fluid container. Each hook 250 may include a button or releasecatch 251 that may be activated by an operator to release the hookmember and allow the operator to slide the hooks 250 downwardly and/orupwardly on the poles 200 until the desired height is reached. As willbe described below, the hooks 250 may be moved to either clamp down onor hold a bulk container that is used to fill one or more of thesyringes in the injector 100 (see for example, FIG. 11A) or may be movedto bring the hook 250 and a multi-dose bulk fluid container (252, 254and 256) to the appropriate position relative to the one or moresyringes in the injector 100 to allow connection with and fluidcommunication between the one or more bulk container and the respectiveone or more syringes (for example, FIGS. 11B, 12A, 12B and 13A). Theoperator may also activate the button 251 to move the hooks 250 upwardlyaway from the syringes in the injector 100.

FIG. 11A shows an example of the retractable pole 200 of the injector100 in the fully deployed position where the at least one hook 250 isdeployed vertically over at least one syringe 253. In this position,shown in FIG. 11A, one or more multi-dose bottles 252 may be connectedto a syringe 253 held within the injector housing 125. The hooks 250 maybe moved downwardly on the poles 200 to bring the hooks 250 into contactwith a bottom surface of the bottles 252 to stabilize the bottles 252when connected to the syringes 253. In one example, the bottles 252 mayhold a bulk amount of a contrast medium. In another example, shown inFIG. 11B, one or more multi-dose fluid bags 254 may be hung from thepivotable hooks 250 in an inverted position over the at least onesyringe 253 and attached to the fluid port of the syringe 253 by a fluidpath (see, for example, FIG. 12B) to allow fluid communication and flowof medical fluid from the multi-dose fluid container 252 or multi-dosefluid bag 254 to the at least one syringe 253. In one example, themulti-dose fluid bag 254 may hold saline. As shown in one example inFIG. 11B, a multi-dose fluid bottle 252 may be provided on the injector100 to provide fluid to a first syringe 253 and a multi-dose fluid bag254 may also be provided to supply fluid to a second syringe 253.

With reference to a non-limiting example in FIGS. 12A and 12B, theinjector 100 may be used with any combination of single-dose fluidcontainers (FIG. 12A) for a single patient and/or with multi-dose fluidcontainers (FIG. 12B) for a single patient. In one example, shown inFIG. 12A, at least one syringe 253 may be filled with fluid from asingle-dose fluid container 256 in fluid communication with the at leastone syringe 253 for example by a spike or other appropriate fluid path.After the syringe 253 has been filled with fluid from the single-dosefluid container 256, the single-dose fluid container 256 may be removedfrom the injector 100 and replaced with another single-dose fluidcontainer. The hooks 250 may stabilize the single-dose fluid container256 on the syringe 253 or may hold the single-dose fluid container 256at the appropriate height above the syringe 253. In another example,shown in FIG. 12B, at least one syringe 253 may be filled with fluidfrom a multi-dose bulk fluid container 252 and/or multi-dose hulk fluidbag 254. The syringe 253 may be connected to and in fluid communicationwith a multi-dose fluid container 252 or bag 254 via a transfer set 257that is connected at one end to the syringe 253 and at another end tothe multi-dose fluid container 252, for example by a spike, to transferfluid therebetween. The multi-dose fluid container 252 may be a bottle(which may contain a bulk amount of contrast medium or other medicalfluid) or a bag (which may include saline). In another example, onesyringe 253 may be connected to a multi-dose fluid bottle 252 and asecond syringe 253 may be connected to a multi-dose fluid bag 254. Themulti-dose fluid bag 254 may hang from a hook 250 supported on the pole200. In various embodiments, the multi-dose fluid bottle 252 may includean insulating or heated sleeve 260 that is received on the pole 200 tomaintain the multi-dose fluid bottle 252 at a desired height relative tothe syringe 253 and to maintain a fluid temperature of the fluid in themulti-dose fluid bottle 252, for example a contrast medium in themulti-dose fluid bottle 252. The multi-dose fluid bottle 252 may beremovably provided within the insulating or heated sleeve 260. Accordingto another example, one syringe 253 may be connected to a single-dosefluid bottle 256 and a second syringe 253 may be connected to amulti-dose fluid bag 254.

With reference to FIGS. 13A and 13B, an embodiment of fluid injectionsystem 10 including injector 100 may be used to provide fluid tomultiple patients in a series of injection procedures, for example twoor more injection procedures spaced over a period of time. As describedabove, multi-dose fluid containers 252, 254 may be connected to one ormore syringes 253 engaged with the injector housing 125 to repeatedlyfill the one or more syringes 253 with fluid from the multi-dose fluidcontainers 252, 254 over the course of a plurality of injectionprocedures. In one example, a multi-dose fluid bottle 252 may beconnected to a first syringe 253 and a multi-dose fluid bag 254 may beconnected to a second syringe 253, in one example, the multi-dose fluidbottle 252 and multi-dose fluid bag 254 may be connected to the syringes253 via a multi-patient use manifold assembly 300 that may be utilizedover a plurality of injection procedures (described in greater detailherein). The manifold assembly 300 and one or more syringes 253connected thereto may be configured to supply fluid from the multi-dosefluid bottle 252 and/or multi-dose fluid bag 254 to multiple patientsover the course of a plurality of injection procedures. An outlet 302defined in the manifold 300 directs fluid out of the manifold 300 to themultiple patients via connection lines, such as a single-patientdisposable fluid path set (single-use disposable sets or “SUDS”) havinga first end for releasable connection with the manifold and a second endconfigured for connection to a needle, catheter or other connectionfeature connected to a patient to provide fluid communication betweenthe manifold and the vasculature of the patient (not shown). Suitablesingle-use disposable sets are described in detail in InternationalApplication Publication No. WO 2015/106107, which disclosure isincorporated in its entirety by this reference. The single-patientdisposable fluid path set may include appropriate connector assembliesand one, two or more check valves to prevent fluid backflow ofpotentially contaminated fluid from the single-patient disposable fluidpath set into the multi-patient use manifold assembly 300.

As shown in FIG. 13B, an air detector coupling 400 may be provided onthe injector 100 according to one example to provide a line presencedetector that detects a line coupling to the manifold 300 and toinitiate an auto prime routine. The auto prime routine assists inremoving any significant amounts of air provided in the patient lines,such as the SUDS. The air detector coupling 400 may include asingle-patient use tubing set or line coupling (SUDS) 402. One end ofthe SUDS coupling 402 may be connected to the manifold assembly 300 andan opposing end of the SUDS coupling 402 may be connected to an excessfluid container 403 or held in position to expel fluid into anappropriate container. An additional portion of the SUDS coupling 402may be held on the excess fluid container 403. The excess fluidcontainer 403 may be held on the injector housing 125 by sliding into acoupling interface 404 extending from the injector housing 125. In oneexample, the coupling interface 404 may include an air detector, such asan ultrasonic air detector, to detect air that may be present in theSUDS coupling 402. During a priming operation, the air detector maydetermine when all or substantially all excess air has been expelledfrom the SUDS coupling 402, and indicate that the system is primed andready for an injection procedure.

The SUDS coupling 402 may be primed before attachment of the SUDScoupling 402 to the vasculature system of the patient. Upon insertion ofthe SUDS coupling 402 into the coupling interface 404, an auto primeprocess may be initiated. Fluid may be pushed through the SUDS coupling402 from the manifold assembly 300, thereby pushing any air present inthe SUDS coupling 402 into the excess fluid container 403. The airstored in the excess fluid container 403 may then be vented toatmosphere. As the air is pushed through the SUDS coupling 402, anyexcess fluid in the SUDS coupling 402 may also be pushed into the excessfluid container 403. During the prime process of the SUDS coupling 402,the coupling interface 404 may monitor and detect the presence of anyair in the SUDS coupling 402. Once the coupling interface 404 hasdetermined that there is no longer air present in the SUDS coupling 402,the SUDS coupling 402 may be removed from the excess fluid container 403and placed in fluid connection with the vasculature of a patient.

The air detector coupling 400 monitors air and fluid passing through theSUDS coupling 402 during the auto prime routine. Once a constant fluidflow is detected to be passing through the SUDS coupling 402, the systemdelivers sufficient further volume of fluid to ensure complete fluidfill of the coiled section of the SUDS coupling 402. The excess fluidcontainer 403 may capture any excess fluid from the initial air/fluidmix delivery or any manufacturing tolerances and accuracy allowances inthe coiled section of the SUDS coupling 402. During the injectionsequence, air and fluid is constantly monitored as it passes through theair detector coupling 400. The system halts injections at a point whenthe volume of air passing through the air detector coupling 400 reachesa pre-determined safety level to protect against injecting the patientwith dangerous volumes of air or air/fluid mix. The air detectorcoupling 400 may be located at the distal end of the SUDS coupling 402(e.g., further from the patient) to allow maximum time for the system toreact to the air detector coupling 400 and stop the injection before theair reaches the patient. The amount of air injected is recorded by thesystem and may be included in a procedure report. Accurate air detectioncan require constant surface contact and a constant contact surface areabetween the SUDS coupling 402 and the coupling interface 404 of the airdetector coupling 400. The SUDS coupling may be inserted into thedetection region of the air detector by pressing the tubing into thedetection region. If the tubing is not fully inserted into the detector,for example by applying insufficient force to insert the tubing into theair detector, inaccurate air detection may result due to lack of fullsurface contact and reading of air present between the tubing and thedetector surface. In certain examples, the present system slides thetubing of the SUDS coupling 402 into the coupling interface 404 of theair detector coupling 400, for example from top to bottom, resulting inimproved and consistent contact between the tubing surface of the SUDScoupling 402 and the coupling interface 404 of the air detector coupling400, thus ensuring that air detection detects air primarily within thetubing.

With reference to FIG. 14A, according to certain examples the fluiddelivery system 10 may also include a fluid warmer 500 to warm themulti-dose and/or single-dose medical fluid container, 252 or 256respectively, and medical fluid contained therein. Certain medicalfluids, such as certain contrast fluids, may have high viscosities atroom temperature, which may affect the fluid flow and injection pressureduring an injection procedure. The viscosity of the medical fluid may bereduced by warming the fluid to above room temperature, such as atemperature at or near body temperature. In one example, the fluidwarmer 500 may be positioned on the fluid delivery system 10 below theinjector housing 125 and may be supported on the lower support portion120. The fluid warmer 500 may be used by a technician to warm at leastone multi-dose fluid bottle 252 or at least one single-dose fluid bottle256 before transferring the fluid in the multi-dose fluid bottle 252into a syringe 253 as described herein. The multi-dose fluid bottle 252may be inserted into and removed from the fluid warmer 500 via openingsdefined in the fluid warmer 500. In one example, the multi-dose fluidbottle 252 may hold a contrast medium that can be warmed with the fluidwarmer 500. In one example, the multi-dose fluid bottles 252 may be heldin a bottle storage tray (not shown) provided in the fluid warmer 500.In one example, the fluid warmer 500 is configured to warm two or moremulti-dose fluid bottles 252. A technician may remove a warmedmulti-dose fluid bottle 252 from the fluid warmer 500 and use forloading syringes for an injection procedure and may replace the warmedmulti-dose fluid bottle 252 with a second multi-dose fluid bottle addedto the fluid warmer 500 to begin warming the second multi-dose fluidbottle. In one example shown in FIG. 14B, the fluid warmer 500 may becylindrical to minimize an air cavity within the fluid warmer 500. Thefluid warmer 500 may be configured to accommodate different sizes ofbottles. Demonstrator electronics 501 may be provided inside of thefluid warmer 500 to control heating elements (not shown) used to warmthe multi-dose fluid bottles 252. The demonstrator electronics 501 mayinclude at least one infrared temperature sensor to record thetemperature of the bottles in the fluid warmer 500. The demonstratorelectronics 501 may be accessed by a technician by removing the rearaccess cover 122 from the fluid delivery system 10. In one example, thefluid warmer 500 may be configured to warm fluid in multi-dose fluidbottles 252 from room temperature to at/near a patient's bodytemperature. In another example, the fluid warmer 500 may be configuredto warm fluid in multi-dose fluid bottles 252 to a temperature in therange of 20° C.-37° C. It is also contemplated for certain examples thatthe fluid may be initially warmed to a higher temperature, such as atemperature in the range of 20° C. to at least 41° C., and allowed tocool to the desired temperature prior to being utilized in an injectionprocedure or may cool to a desired temperature within the syringe orwhile flowing through the one or more tubing sets. In variousembodiments, a technician may control the temperature in the fluidwarmer 500. The fluid warmer 500 and/or the controller GUI may include atemperature display to show the current temperature in the fluid warmer500 and/or the final heated temperature in the fluid warmer 500. Incertain embodiments, the controller may prevent an injection procedurewhen a measured temperature of the fluid is outside a desired range,such as above body temperature. The fluid warmer 500 may also log thetemperatures provided in the fluid warmer 500 and may use thisinformation with the rest of the fluid delivery system 10. In oneexample, the fluid warmer 500 may be configured to maintain apredetermined temperature to ensure the bottles are heated at thedesired temperature. In one example, the fluid warmer 500 may usemicrowave or infra-red heating to provide the required energy to heatthe bottles. In another example, the fluid warmer 500 may utilizeresistive heating to heat the bottles. Fan-forced air may be used toimprove the heating in the fluid warmer 500, which may be used inconjunction with a downstream heating system. The fluid warmer 500 mayalso assist in sterilizing or maintaining sterility of the multi-dosefluid bottles 252 before being used with the injector 100. Warming thefluid in the multi-dose fluid bottles 252 also makes the injection ofthe fluid into a patient more comfortable for the patient. Warming thefluid in the multi-dose fluid bottles 252 also allows for higher flowrates during injection because the viscosity of the fluid is reduced byhigher temperatures generated by the fluid warmer 500. In one example,the fluid in the multi-dose fluid bottle 252 may be warmed toapproximately the patient's body temperature so, upon injection of thefluid into the patient, the fluid is at or near the same temperature asthe patient's body. In one example, the fluid warmer 500 may be manuallyoperated by the technician and activated/deactivated as needed by thetechnician. Alternatively, the fluid warmer 500 may be automaticallyactivated upon insertion of a multi-dose fluid bottle 252 into the fluidwarmer 500 and automatically deactivated upon removal of the multi-dosefluid bottle 252 from the fluid warmer 500. The fluid warmer 500 may bedeactivated when the bottle or bottles are empty. The fluid warmer 500may also be configured to receive a multi-dose fluid bag 254 or asingle-dose bottle or bag. Further, the system may record the details ofthe heated bottles 252 by a barcode scanner (not shown), such as thefinal temperature and/or duration of heating of the bottles. Thisinformation may be stored in records for compliance requirements. Thetemperature at injection may also be recorded by a sensor (not shown) atthe syringe and may be included in a procedure report. Suitablenon-limiting structures and direct methods for measuring fluidtemperature at the syringe may be found for example in U.S. ProvisionalApplication No. 62/005,346. Temperature sensing of the fluid within thesyringe may also be performed using indirect methods, such as infraredreadings.

With reference to FIG. 15, a recognition system 600 may also be providedon the injector 100. The recognition system 600 may be removablyprovided on the support portion 118 of the injector 100. In one example,the recognition system 600 may be positioned behind the syringes 253when the syringes 253 are being filled with fluid from a single- ormulti-dose fluid bottle or bag. The recognition system 600 may beconfigured to identify various features and/or properties of the fluidin each syringe 253, as well as the type of disposable syringe. Based onthe information identified by the recognition system 600, the injector100 may adjust its operating parameters to achieve desired filling andinjection parameters. Examples of suitable recognition systems aredescribed in U.S. Application Publication No. 2017/0056603, incorporatedherein by this reference.

With reference to FIGS. 16-18C, embodiments of manifold assemblies 300and syringe assemblies 700 according to various examples are described.The manifold assembly 300 and syringe assembly 700 may be configured foruse in a multi-patient, multi-dose injector 100. The manifold assembly300 may be configured to fluidly connect at least one multi-dose bottleor bag to at least one syringe assembly 700 to allow filling of the atleast one syringe in the syringe assembly 700 with a medical fluid fromthe at least one multi-dose bottle or bag and allow delivery of themedical fluid from the at least one syringe to the patient via asingle-patient use tubing set (SUDS, not shown) connected to an outlet302 of the manifold assembly 300 at a first end and the patient at asecond end. According to certain embodiments, the manifold assembly 300may include a lower body member 303, a middle body member 304, and anupper body member 305. The lower body member 303 is configured to fitwithin or attached to a lower portion of the middle body member 304. Theupper body member 305 is configured to fit within or attach to an upperportion of the middle body member 304. As shown in FIG. 17A, the upperbody member 305 includes at least one fluid conducting element, such asa spike member 306, used to pierce or connect to a septum or cap on afluid bottle or bag. It is to be understood that fluid conductingelements other than a spike member can also be used, such as a fluidconnector. The at least one spike member 306 creates fluid communicationbetween the fluid bottle or bag and the manifold assembly 300. The atleast one spike member 306 may have a pointed end used to pierce theseptum or cap on the fluid bottle and at least one fluid path to allowfluid communication between the fluid bottle or bag and the manifoldassembly 300. In one example the at least one spike member 306 mayfurther include a second fluid path to allow air or other gas to passinto the fluid bottle or bag to equalize the pressure in the interior ofthe fluid bottle or bag.

With reference to FIGS. 17B and 17D, the middle body member 304 definesan upper cavity 308 (FIG. 17D) and a lower cavity 309 (FIG. 17B). Theupper cavity 308 is configured to receive or attach to the upper bodymember 305 and the lower cavity 309 is configured to receive or attachto the lower body member 303. The middle body member 304 also definesthe outlet opening 302 that is configured to connect the manifoldassembly 300 to single-patient use fluid lines that are fluidlyconnected to the vasculature of the patient. The middle body member 304also includes a dividing plate 310 that separates the upper cavity 308from the lower cavity 309. As shown in FIG. 17B, at least a pair offluid paths 311 a, 311 b may be defined in the lower surface of thedividing plate 310. Each fluid path 311 a, 311 b may define a pair ofports 312 a-312 d in the dividing plate 310. A check valve diaphragm 313a, 313 b may be provided in two of the ports 312 a, 312 d on the bottomsurface of dividing plate 310. In another example, instead of providingthe check valve diaphragms 313 a, 313 b, a floating disc valve may beprovided in two of the ports 312 a, 312 d on the bottom surface of thedividing plate 310. Several examples of such a floating disc valve aredisclosed and illustrated in U.S. Pat. No. 9,526,829, which disclosureis incorporated by reference in its entirety.

As shown in FIG. 17D, a plurality of fluid paths 314 a-314 c may bedefined in an upper surface of the dividing plate 310. One fluid path314 b may define two ports to receive check valve diaphragms 315 a, 315b. In another example, instead of providing the check valve diaphragms315 a, 315 b, a floating disc valve may be provided in the two ports 312b, 312 c, such as the examples of floating disc valves disclosed in U.S.Pat. No. 9,526,829. The two ports 312 b, 312 e may also be defined bythe fluid paths 311 a, 311 b. Two additional ports 316 a, 316 b may bedefined in the dividing plate 310 with the ports 312 a, 312 d toestablish fluid communication with the spike members 306 of the upperbody member 305 and connectors 317 a, 317 b of the lower body member303, described below.

As shown in FIG. 17B, the lower body member 303 may include connectors317 a, 317 b configured to establish fluid communication between themanifold assembly 300 and the syringe assemblies. Other examples ofsuitable connectors are described in U.S. Provisional Application No.62/259,891. The connectors 317 a, 317 b are provided in fluidcommunication with the ports 312 a, 312 d defined in the dividing plate310. The check valve diaphragms 313 a, 313 b are positioned between theconnectors 317 a, 317 b and the ports 312 a, 312 d. The check valvediaphragms 313 a, 313 b permit fluid to flow from the spike members 306on the manifold assembly 300 to the syringe assemblies, but does notallow fluid to backflow from the syringe assemblies through theconnectors 317 a, 317 b in the manifold assembly 300 and into thesingle- or multi-dose bottles or bags attached to the spike members 306.Instead, during injection of fluid into a patient, the fluid is directedback into the manifold assembly 300 against the bottom surface of thecheck valve diaphragms 313 a, 313 b, through the fluid path 311 a, 311b, ports 312 a, 312 b, check valve diaphragms 315 a, 315 b, and alongfluids path 314 b defined in an upper surface of the dividing plate 310,and through the outlet 302 to the patient line. The check valvediaphragms 315 a, 315 b direct the fluid to the outlet 302 and preventbackflow to the connectors 317 a, 317 k The fluid paths 311 a, 311 b,the ports 312 b, 312 c, and the fluid path 314 b establish fluidcommunication between the connectors 317 a, 317 b and the outlet 302.

With reference to FIGS. 1.7B-17E, the assembly of the manifold assembly300 is described according to one example. In a first step, the checkvalve diaphragms 313 a, 313 b are inserted into the ports 312 a, 312 ddefined in the dividing plate 310. In a next step, the lower body member303 is positioned on the middle body member 304. Subsequently, the lowerbody member 303 and the middle body member 304 are flipped over. Thelower body member 303 is then welded or adhered to the middle bodymember 304 along a weld or adhesion path 318 that encircles the fluidpaths 311 a, 311 b defined in the dividing plate 310 to prevent fluidfrom flowing out of the fluid paths 311 a, 311 b. In one example, laserwelding may be used to create a concentrated heat source in therespective components permitting the components to weld to and form withone another. In one example, the laser welding direction may be directedfrom a top surface of the dividing plate 310, through the dividing plate310, and into the lower body member 303. Alternatively, an appropriateheat weld protocol or application of an appropriate adhesive may securethe lower body member 303 to dividing plate 310. Next, the check valvediaphragms 315 a, 315 b are positioned in the ports defined in the fluidpath 314 a, 314 c on the top side of dividing plate 310. The fluid paths314 a, 314 e, and 314 b are then welded or adhered through a top surfaceof the dividing plate 310 along weld paths 319 a-319 c for example bylaser welding, heat welding or other adhesive process. The upper bodymember 305 is then pressed on the middle body member 304 to form the twoelements together based on adhesion created by the welding or adhesionprocess. The resulting manifold assembly 300 is illustrated in FIG. 17E.

With reference 18A-18C, an example of a syringe assembly 700 of one ofthe one or more syringes 253 configured for connection to the manifoldassembly 300 is described. The syringe assembly 700 includes a barrel701, a conical distal end 702, and locking features 703, as describedfor example in U.S. Pat. Nos. 6,652,489; 9,173,995; and 9,199,033,configured to secure the syringe assembly 700 in an injector 100. Aplunger (not shown) may be slidably contained within the barrel 701 todraw in and expel fluid from the syringe assembly 700. The syringeassembly 700 may also include an adapter 704 and flow directing assembly705 provided in an opening defined in the conical distal end 702.Examples of suitable adapters and flow directing assemblies aredescribed in International Application Publication Nos. WO 2017/091635;WO 2017/091636; and WO 2017/091643, the disclosures of which areincorporated herein by this reference. The adapter 704 is configured forconnection with the connectors 317 a, 317 b of the manifold assembly300. The flow directing assembly 705 may be seated on a protrusion 706extending from an inner surface of the conical distal end 702 such thata portion of the flow directing assembly 705 is held between theprotrusion 706 and the adapter 704. The adapter 704 may be positioned ontop of the flow directing assembly 705 within the conical distal end702. The adapter 704 and the flow directing assembly 705 may beconnected to one another and the conical distal end 702 using welding orother adhesion directed along line A, for example by a laser welding orother process as described herein. The flow directing assembly 705 isconfigured to direct fluid being drawn into the syringe assembly 700along the inner walls of the barrel 701 to avoid creating turbulent flowin the syringe assembly 700. The fluid is directed along the inner wallsof the barrel 701 to create more laminar flow into the barrel 701, whichavoids the creation of air bubbles from turbulent flow in the syringeassembly 700. The flow directing assembly 705 may include a main bodyhaving two angled surfaces 707 a, 707 b that direct the fluid towardsthe inner walls of the barrel 701.

With reference to FIGS. 19A-19D, a manifold assembly 800 according to anexample suitable for use with a single-dose injector is described. Themanifold assembly 800 includes a lower body member 801, a middle bodymember 802, and an upper body member 803. The lower body member 801 isconfigured to fit within or attach to a lower portion of the middle bodymember 802. The upper body member 803 is configured to fit within orattached to an upper portion of the middle body member 802. As shown inFIG. 19A, the upper body member 803 includes at least one fluidconducting element, such as a spike member 804, used to pierce orconnect to a septum or cap on a fluid bottle. It is to be understoodthat fluid conducting members other than a spike member can also beused, such as a fluid connector. The spike member 804 creates fluidcommunication between the fluid bottle and the manifold assembly 800.The spike member 804 may have a pointed end used to pierce the septum orcap on the fluid bottle and at least one fluid path to allow fluidcommunication between the fluid bottle or bag and the manifold assembly800. In one example the at least one spike member 804 may furtherinclude a second fluid path to allow air or other gas to pass into thefluid bottle or bag to equalize the pressure in the interior of thefluid bottle or bag. The upper body member 803 may also define at leastone port 805.

The middle body member 802 defines an upper cavity 806 and a lowercavity 807. The upper cavity 806 is configured to receive the upper bodymember 803 and the lower cavity 807 is configured to receive the lowerbody member 801. The middle body member 802 also includes a dividingplate 808 that separates the upper cavity 806 from the lower cavity 807.As shown in FIG. 19A, a fluid path 809 may be defined in the uppersurface of the dividing plate 808. The fluid path 809 may define a pairof ports 810 a, 810 b in the dividing plate 808. A check valve diaphragm811 a, 811 b may be provided in the ports 810 a, 810 b to preventbackflow from the patient line into the syringes. In another example,instead of providing the check valve diaphragms 811 a, 811 b, a floatingdisc valve may be provided in two of the ports 810 a, 810 b. Severalexamples of such a floating disc valve are disclosed and illustrated inU.S. Pat. No. 9,526,829. Two additional ports 812 a, 812 b may bedefined in the dividing plate 808. The ports 812 a, 812 b are in fluidcommunication with the spike members 804 of the upper body member 803.Ports 812 a, 812 b may have check valve diaphragms 818 a, 818 b on abottom portion to prevent backflow of fluid from the syringe into thefluid bottles or bags. It is also contemplated that floating disc valvesmay be used in place of the check valve diaphragms 818 a, 818 b.

The lower body member 801 may define at least two fluid paths 813 a, 813b. The lower body member 801 also defines an outlet port 814 in fluidcommunication with fluid path 809 through which fluid may be directed tothe patient. The outlet port 814 may be defined between the fluid paths813 a, 813 b. Fluid from a fluid bottle or bag spiked on the upper bodymember 803 is directed through the ports 812 a, 812 b in the middle bodymember 802 and into the syringes through fluid paths 817 a, 817 bdefined in the lower body member 801 during a syringe filling process.The fluid is then expelled from the syringes into the fluid paths 813 a,813 b, through ports 810 a, 810 b in the dividing plate 808 and checkvalve diaphragm 811 a, 811 b into fluid path 809 defined in the middlebody member 802. The check valve diaphragms 811 a, 811 b allow flow offluid from the fluid paths 813 a, 813 b defined in the lower body member801 to the fluid path 809 defined in the middle body member 802, butprevents backflow of fluid in a reverse direction (i.e., flow from thefluid path 809 defined in the middle body member 802 to the fluid paths813 a, 813 b defined in the lower body member 801). After the fluidflows into the fluid path 809, the fluid is directed out through theoutlet port 814 defined in the lower body member 801 to the patient viaa patient line (not shown), such as a catheter or IV line.

With reference to FIGS. 19B-19D, a method of assembling the manifoldassembly 800 is described. In a first step, the lower body member 801 ispositioned within the lower cavity 807 defined by the middle body member802. Check valve diaphragms are inserted into lower face of ports 812 a,812 b and lower body member 801 is then welded or adhered to thedividing plate 808 of the middle body member 802, for example by laserwelding. In one example, the welding or adhesion is performed alongweld/adhesion paths 815 a, 815 b directed around the fluid paths 813 a,813 b defined in the lower body member 801 to permit adhesion of thelower body member 801 to the middle body member 802. The check valvediaphragms 811 a, 811 b are then inserted into the ports 810 a, 801 bdefined in the dividing plate 808. The upper body member 803 is thenpositioned against the dividing plate 808 in the upper cavity 806 of themiddle body member 802. The upper body member 803 is then welded oradhered to the middle body member 802 along a weld path 816 that isdirected around the fluid path 809 and ports 810 a, 810 b, for exampleby laser welding. After these steps have been completed, the manifoldassembly 800 (FIG. 190) is been fully assembled.

While various examples of the injector 100, manifold assemblies 300,800, and syringe assemblies 700 were provided in the description, thoseskilled in the art may make modifications and alterations to theseexamples without departing from the scope and spirit of the disclosure.For example, it is understood that this disclosure contemplates that, tothe extent possible, one or more features of any example may be combinedwith one or more features of any other example. Accordingly, theforegoing description is intended to be illustrative rather thanrestrictive. The disclosure herein is defined by the appended claims.All changes to the disclosure that fall within the meaning and range ofequivalency of the claims are to be embraced within their scope.

What is claimed is:
 1. A syringe manifold for a fluid injector assembly,the syringe manifold comprising: an upper body member, the upper bodymember comprising at least one spike member for piercing a fluidcontainer; a middle body member defining an upper cavity and a lowercavity, wherein the upper body member is connected with the upper cavityof the middle body member, and wherein the middle body member furthercomprises: at least one first fluid path defined in an upper surface ofthe middle body member; at least one second fluid path defined in alower surface of the middle body member; at least one first port definedby the at least one first fluid path; at least one second port definedby the at least one first fluid path and the at least one second fluidpath; and an outlet for connection of the syringe manifold to at leastone fluid delivery device; and a lower body member connected with thelower cavity of the middle body member, the lower body member comprisingat least one connector for connection of the lower body member to asyringe assembly, wherein the at least one first port on the middle bodymember establishes fluid communication between the at least one spikemember and the at least one connector, and wherein the at least onefirst fluid path, the at least one second fluid path, and the at leastone second port establish fluid communication between the at least oneconnector and the outlet of the middle body member.
 2. The syringemanifold of 1, wherein the at least one spike member comprises two spikemembers, and wherein the at least one connector of the lower body membercomprises two connectors.
 3. The syringe manifold of claim 2, whereinthe at least one second fluid path defined in the lower surface of themiddle body member comprises two second fluid paths in the lower surfaceof the middle body member, and wherein the at least one first port andthe at least one second port of the middle body member comprise twofirst ports and two second ports, respectively, extending through themiddle body member.
 4. The syringe manifold of claim 1, wherein the atleast one first port is defined at a first end of the at least onesecond fluid path defined in the lower surface of the middle bodymember, and wherein the at least one second port is defined at a second,opposing end of the at least one second fluid path defined in the lowersurface of the middle body member.
 5. The syringe manifold of claim 1,further comprising at least one check valve diaphragm in each of the atleast one first port and the at least one second port.
 6. The syringemanifold of claim 5, wherein the at least one check valve diaphragm ofthe at least one fluid port comprises a first check valve diaphragmpositioned between the at least one spike member and the at least oneconnector and permits fluid flow from the at least one spike member tothe at least one connector and prevents fluid flow from the at least oneconnector to the at least one spike member, and wherein the at least onecheck valve diaphragm of the at least one second port comprises a secondcheck valve diaphragm positioned between the at least one connector andthe outlet of the middle body member and permits fluid flow from the atleast one connector to the outlet and prevents fluid flow from theoutlet to the at least one connector.
 7. The syringe manifold of claim1, wherein at least one floating disc valve is provided in each of theat least one first port and the at least one second port.
 8. The syringemanifold of claim 7, wherein the at least one first floating disc valveis positioned between the at least one spike member and the at least oneconnector and permits fluid flow from the at least one spike member tothe at least one connector and prevents fluid flow from the at least oneconnector to the at least one spike member, and at least one secondfloating disc valve is positioned between the at least one connector andthe outlet of the middle body member and permits fluid flow from the atleast one connector to the outlet and prevents fluid flow from theoutlet to the at least one connector.
 9. The syringe manifold of claim1, wherein at least one of the upper body member and the lower bodymember are welded or adhered to the middle body member.
 10. The syringemanifold of claim 1, further comprising at least one syringe connectedto the at least one connector.
 11. A syringe manifold for a fluidinjector assembly, the syringe manifold comprising: an upper body membercomprising at least one spike member for piercing a septum of at leastone fluid container; a middle body member defining an upper cavity and alower cavity, wherein the upper body member is connected with the uppercavity of the middle body member, the middle body member furthercomprising: at least one fluid path in an upper surface of the middlebody member; at least one first port defined by a dividing plate of themiddle body member; and at least one second port defined by the at leastone fluid path; and a lower body member connected with the lower cavityof the middle body member, the lower body member comprising: at leastone connector for connecting the lower body member to a syringeassembly; at least one second fluid path; and an outlet for connectingthe syringe manifold to at least one fluid delivery device, wherein theat least one first port defined by the dividing plate of the middle bodymember establishes fluid communication between the at least one spikemember and the at least one connector, and wherein the at least onesecond fluid path defined in the lower body member, the at least onefirst port defined by the dividing plate of the middle body member, theat least one fluid path defined in the upper surface of the middle bodymember, and the at least one second port defined in the middle bodymember establish fluid communication between the at least one connectorand the outlet of the lower body member.
 12. The syringe manifold ofclaim 11, wherein the at least one spike member of the upper body membercomprises two spike members, and wherein the at least one connector ofthe lower body member comprises two connectors.
 13. The syringe manifoldof claim 12, wherein the at least one second fluid path of the lowerbody member comprises two second fluid paths, and wherein the at leastone first port of the middle body member comprises two first portsextending through the middle body member and the at least one secondfluid port comprises two second fluid ports.
 14. The syringe manifold ofclaim 11, wherein the at least one first port provided in the middlebody member is positioned adjacent a first end of the at least onesecond fluid path defined in the lower body member, and wherein the atleast one second port provided in the middle body member is positionedadjacent a second, opposing end of the at least one second fluid pathdefined in the lower body member.
 15. The syringe manifold of claim 11,further comprising at least one check valve diaphragm or floating discvalve positioned between the at least one spike member of the upper bodymember and the at least one connector of the lower body member.
 16. Thesyringe manifold of claim 11, further comprising at least one syringeconnected to the at least one connector.